I am a professor of cardiology, epidemiology, and public health at the Yale University School of Medicine and director of the Yale-New Haven Hospital Center for Outcomes Research and Evaluation I also serve on numerous cardiovascular care committees for national organizations, including the American Heart Association and the American College of Cardiology and am an elected member of the Association of American Physicians, the American Society for Clinical Investigation, and the Institute of Medicine. I've published more than 500 articles and am the author of the book, "The Expert Guide to Beating Heart Disease."

The FDA and Avandia: What Took So Long?

When the Food and Drug Administration decided to restrict the use of Avandia, FDA Commissioner Margaret Hamburg said, “The FDA is taking this action today to protect patients, after a careful effort to weigh benefits and risks.”

Then 8 months passed.Business as usual, with no change in prescribing requirements or in the way risk is communicated to patients.

Finally, the way the drug is prescribed will undergo major changes. Prescribers will need to be certified, which will involve a training program and a signed agreement that the prescribers will register patients who take the drug. The drug will only be dispensed by certified pharmacies that have a system in place to verify that the prescriber is certified and that the patient is enrolled in a registry. Patients must sign a form that states, in part, that “I understand the risk information that my doctor or healthcare provider has talked about with me, including that these medicines may increase my risk of having a heart attack.”

This system will be implemented over the subsequent 6 months. That’s a total of fourteen months elapsed before the way patients and doctors access Avandia (rosiglitazone), manufactured by GlaxoSmithKline, will change.

The announcement yesterday by the FDA revealed a program that will impose strong oversight and require that information about risk be communicated to patients by individuals who are trained to provide it. The program will ensure that patients are informed if they decide to take this medication.This would merit applause if not for the months that passed without action.

If patients were deemed by the FDA to be at risk last September – if they were thought to be inadequately informed about the risk with the current label – if pharmacies were considered unprepared to provide the needed education about risk – and a strong response was felt necessary… why was it not considered urgent to implement the new system?

Sure, the implementation of such a system is not trivial. There is a requirement for the coordination of many groups and the development of an infrastructure that can support the requirements without disrupting patient treatment plans. But, this issue concerns drug safety and a risk of a heart attack, a dangerous complication.

Imagine a busy intersection where major accidents are occurring regularly. Your town determines that you need a stoplight at the intersection because the stop sign is inadequate. The town leaders announce to great fanfare that the stop sign will be replaced with the stoplight and lights will be added to illuminate the area at night. Then nothing happens. And the accidents continue. Finally, almost a year later, a stoplight is installed – too late for many drivers.

The restrictions imposed by the FDA are part of a REMS. REMS is shorthand for a Risk Evaluation and Mitigation Strategy. The FDA Amendments Act of 2007 authorized the FDA to require companies to provide a strategy to protect the interests of patients when there are particular concerns about the balance of benefits and risks for a certain drug.

Sometimes the FDA has required only that the company issue a medication guide or a communication plan to ensure that information is disseminated. For example, each prescription of Fosamax (alendronate), a drug produced by Merck to treat weak bones, is required to include a medication guide to inform patients about the possible risk of unusual thigh bone fractures. Sometimes the requirements are much more stringent – as they are with Avandia.

We can debate many points about the necessity and effectiveness of these strategies. Are they required too often or not often enough? Are they making patients safer? What became clear yesterday is that the system moves too slowly. If the FDA needs to act to protect patients – if that decision is made – then it should act quickly.

Harlan M. Krumholz MD, SM is the Harold H. Hines, Jr. Professor of Medicine and Epidemiology and Public Health at Yale University School of Medicine.

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